SmartWATCHes for Detection of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— WATCHAF  

Official title:

SmartWATCHes for Detection of Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956343
• Other study ID #: 2016-01175
• Status: Completed
• Phase: N/A
• First received: November 2, 2016
• Last updated: January 12, 2018
• Start date: December 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this trial the Preventives Heartbeats algorithm will be tested in two wearable devices for its specificity and sensitivity to distinguish between AF and SR.

Description:

Introduction

Particularly in stroke prevention, the detection of atrial fibrillation is of pivotal importance. Recent studies have impressively confirmed the merits of long-term monitoring. Nevertheless, and despite very mature technology, the currently available methods like long-term ECG with conductive adhesive electrodes or implantable loop recorders are burdened with disadvantages in that they are inconvenient, costly and/or invasive. A predecessor study gave us the possibility to test an app that employs photoplethysmographic signals on a smartphone camera—similar to pulse oximetry technology—to distinguish between atrial fibrillation and sinus rhythm. That retrospective study achieved a sensitivity and specificity of 95% (Krivoshei et al., Europace 2016). The prospective follow-up study DETECT AF pro is currently being conducted in cooperation with Prof. Dörr in Greifswald, Germany.

Our research group has been involved with testing the app's quality in clinical settings before implementing it for use. This procedure differs markedly from the otherwise common practice of marketing qualitatively inferior "health apps" without any clinical testing. There is no app equipped with comparable technology worldwide. The WATCH AF study is the first study on sophisticated rhythm analysis using a smartwatch worldwide.

Study design

Prospective, blinded, multicenter study.

The blinded data will be evaluated and monitored externally.

An interim analysis to assess signal quality will be performed after inclusion of 50% of the planned subjects. If there are <10% non-evaluable signals, the number of subjects will be adjusted accordingly. The aim is to enroll 600 evaluable subjects.

Methods

The subjects will be asked to place a smartwatch on each arm to allow their pulse curve to be recorded for five minutes. At the same time, an ambulatory ECG system will take a synchronous ECG for reference. The ECG system employed is equipped with a validated automatic atrial fibrillation detector, used as a reference for assignment to groups. Data will be collected on person-related information, comorbidities and medication (estimated overall duration/patient <20 min). No follow-up is planned. Analogous to predecessor studies, the pulse wave curve data are coded with the patient's identification number (ID) and externally analyzed at Preventicus; based on the results, the patients will be assigned to SR/AF groups. After evaluation of all files, the grouped results will be aggregated, unblinded and evaluated under monitoring.

Primary target parameters are the app's sensitivity and specificity in correctly detecting atrial fibrillation compared to an automatically interpreted ECG.

Secondary target parameters include the proportion of non-evaluable recordings in the overall study, differences between the two smartwatches and the app's sensitivity and specificity in patients with >2% premature beats.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 651
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Subjects of legal age,

• patients with either sinus rhythm (Group SR) or atrial fibrillation (Group AF)

• signed informed consent form

Exclusion Criteria:

• Legally incompetent persons

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Five minutes pulse wave recording
Patients will wear a smart watch and a wristband each at one arm. A standard egg (lead I) and pig signals from the wearables will be recorded for five minutes.

Locations

Country	Name	City	State
Germany	Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin B	Greifswald
Switzerland	University Hospital Basel	Basel	BS

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	University Hospital Greifswald

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (1)

Krivoshei L, Weber S, Burkard T, Maseli A, Brasier N, Kühne M, Conen D, Huebner T, Seeck A, Eckstein J. Smart detection of atrial fibrillation†. Europace. 2017 May 1;19(5):753-757. doi: 10.1093/europace/euw125. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correct detection of AF	Sensitivity and specificity of the Preventicus Heartbeats App to distinguish between AF and SR	5 minutes
Secondary	Differences in correct detection of AF between Smartwatch and Wristband	Smartwatch and Wristband will be worn simultaneously. As there is no difference in rhythm between left and right lower arm it will be analyzed if there are differences in the primary outcome between the two devices.	5 minutes
Secondary	Reduced sensitivity and specificity in patients with >2% premature beats	Patients in the SR group will be screened for premature beats. The ones with >2% will be taken for an second analysis to validate if the sensitivity of the algorithm is less good for patients with a high number of premature beats.	5 minutes